Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit (ICU) who received continuous glucose monitoring (CGM) vs point of care (POC) glucose monitoring. The study will examine relevant outcomes for patients in the ICU with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Diabetes Mellitus; Hypoglycemia; Critical Illness
• Intervention / Treatment: Device: Continuous glucose monitoring; Device: Point of care glucose monitoring

Detailed Description

Study Purpose:

The purpose of this study is to compare the use of continuous glucose monitoring (CGM) versus point of care (POC) glucose monitoring in the intensive care unit (ICU) setting for differences in glycemic control and other important outcomes.

Research Plan:

This will be a prospective, single-center, randomized comparative trial of adult patients at North Florida/South Georgia Veterans Health System anticipated to be admitted to an ICU for a minimum of 48 hours after enrollment. Study participants will be randomly assigned to one of the study groups (CGM or POC) after being found eligible for inclusion and giving consent to participate. The CGM group will receive glycemic management based on CGM readings. The POC group will receive glycemic management based on POC glucose readings.

Study Outcomes:

Groups will be compared for differences in clinical and safety outcomes. The primary outcome will be the proportion of time in target range (BG 70-180mg/dL). Secondary outcomes will include mean glucose, hypoglycemia, hyperglycemia, ICU length of stay, mortality, glucose variability, cost, and patient satisfaction. Safety outcomes will include new infection, acute kidney injury, delirium, agitation, and pain.

Analysis Methods:

Descriptive statistics and inferential statistical methods will be used as appropriate to report findings of this study.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • North Florida/South Georgia Veterans Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients age 18-89
• Past medical history of any diabetes mellitus OR patients with at least 1 measured BG of 180 being treated with insulin (subcutaneous or infusion)
• Enrollment will occur within 72 hours after being admitted to an ICU if history of diabetes
• Enrollment will occur within 72 hours after developing hyperglycemia in ICU if no diabetes

Exclusion Criteria:

• Pregnant patients
• Patients using CGMs in the outpatient setting
• Diagnosis of diabetic ketoacidosis (DKA)
• Diagnosis of hyperosmolar hyperglycemic state (HHS)
• Anticipated to require prone positioning while on insulin therapy
• Any contraindications to CGMs based on manufacturer labeling
• BG above maximum reading for CGM (e.g. greater than 400 mg/dL)
• Receiving medication that could interfere with CGM readings (based on manufacturer specifications)
• Receiving any dose of hydroxyurea as this could falsely elevate the sensor readings (if applicable for specific CGM)
• Receiving greater than 1,000mg acetaminophen every 6 hours in any form as this could falsely elevate the sensor readings (if applicable for specific CGM)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Glucose Monitoring; Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.	Device: Continuous glucose monitoring; Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
Active Comparator: Point of Care Glucose Monitoring; Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture	Device: Point of care glucose monitoring; Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Target Blood Glucose Range (BG 70-180mg/dL)	Percentage of time within time glucose range based on CGM readings	For duration of study enrollment (up to 10 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agitation	Richmond agitation scores (-5 to +4), with scores of +2 or more indicated agitation.	Assessed daily, For duration of study enrollment (up to 10 days)
Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL)	Percentage of time with BG less than 54 mg/dl as measured by CGM	For duration of study enrollment (up to 10 days)
Time in Hypoglycemic Range (BG 54-69 mg/dL)	Percentage of time in this glucose range as measured by CGM	For duration of study enrollment (up to 10 days)
Time in Hyperglycemic Range (BG 181-250 mg/dL)	Percentage of time in this glucose range as measured by CGM	For duration of study enrollment (up to 10 days)
Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL)	Percentage of time in this glucose range as measured by CGM	For duration of study enrollment (up to 10 days)
ICU Length of Stay	Total time (in days or hours) in the intensive care unit	At time of ICU discharge or death (assessed up to 1 month)
ICU Mortality	Death from any cause during ICU stay	At time of ICU discharge or death (assessed up to 1 month)
30 Day Mortality	Death from any cause at 30 days after admission to the ICU	At 30 days or time of death
Cost Associated With Monitoring	Monetary value assigned to blood glucose monitoring	For duration of study enrollment (up to 10 days)
Mean Blood Glucose	Average blood glucose (< 180 mg/dl) during the study timeframe	For duration of study enrollment (up to 10 days)
Glucose Variability	a. % coefficient of variation = SD/mean BG*100%	For duration of study enrollment (up to 10 days)
Patient Satisfaction	Patient satisfaction with glucose monitoring as assessed by survey on Likert Scale (1-5). Score of 1 being 'very dissatisfied' to score of 5 being 'very satisfied.'	Once at completion of study enrollment (at day 10 or sooner)
New Infection	Any infection diagnosis that was not present upon admission to the ICU	Assessed daily, For duration of study enrollment (up to 10 days)
New Acute Kidney Injury	New acute kidney injury (based on Acute Kidney Injury Network guideline definitions) not present upon admission to the ICU	Assessed daily, For duration of study enrollment (up to 10 days)
ICU Delirium	Development of ICU delirium, based on Confusion Assessment Method for the ICU (CAM-ICU) score, with any positive score indicating presence of delirium.	Assessed daily, For duration of study enrollment (up to 10 days)
Pain Associated With Glucose Monitoring	Patient reported pain associated with glucose monitoring	Assessed daily, For duration of study enrollment (up to 10 days)

Collaborators and Investigators

• Sponsor: Malcom Randall VA Medical Center
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Andrew J Franck, PharmD, US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Hypoglycemia; Critical Illness; Hyperglycemia
• Other Study ID Numbers: 202201063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes